Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania

描述(由申请人提供)：拟议研究的目标是进一步完善和评估一种不显眼的、提高认识和监测设备(AEMD)，该设备将有助于治疗脱毛症(TTM)。TTM与严重的社会功能障碍有关，并往往对自尊和福祉产生深远的负面影响。保守估计表明，0.6%的美国人口，即约180万人，符合TTM的完整诊断标准，约750万美国居民有严重的拔发问题。在接受治疗的患者中，60%到70%对标准的行为和药物治疗完全或部分无效，因此可能会从这种设备中受益。治疗TTM的最佳实践包括一种被称为习惯逆转疗法(HRT)的行为疗法。HRT要求TTM患者意识到他们的拉毛行为，但大多数TTM患者在他们意识到的情况下拉扯他们的头发。HRT还要求TTM患者记录他们拉毛的频率和持续时间，但一个人不可能监测他们不知道的行为。我们的第一阶段工作已经产生了一个解决这两个问题的原型设备(AEMD)。原型AEMD向TTM患者发出信号，如果他们的手靠近他们的头发，从而使与拉扯相关的行为变得意识到。原型AEMD还记录与拔头发相关的事件的时间、日期、持续时间和用户分类。我们发表的先导研究和随后的研究证实，AEMD原型成功地提醒TTM患者与拉扯相关的行为，并在实验室环境中监测与TTM相关的行为。在技术创新方面，该项目有可能开发出第一个可用的小型化、可穿戴、患者互动的实时数据收集和接近感测设备，既能在精神疾病症状出现时向患者发出警报，又能跟踪问题的频率和强度。为AEMD开发的专利技术有可能对其他一系列健康/精神健康状况或工业应用具有巨大价值。我们第二阶段的总体目标是进一步完善AEMD，并评估其在专业指导的习惯逆转治疗的开放试验课程中使用时的接受度和实用性。据推测，AEMD将被TTM患者及其临床医生热情接受，并将在临床试验期间按设计发挥作用。第二阶段的AEMD将包括一个戴在每个手腕上的S手镯/手表，另一个放置在脖子后部的元件，以及一个传呼机般的警报装置，可以戴在腰带上或口袋里。如果AEMD被发现是有用和有效的，有可能显著减少TTM的症状及其相关的功能损害。AEMD还具有改善对TTM行为的评估和监测的巨大潜力，这对临床医生计划治疗和研究人员评估各种治疗策略的疗效具有非常重要的价值。 与公共卫生相关：该第二阶段项目包括继续设计、开发和评估一种辅助治疗毛发狂症的装置。该设备增强了对拉动行为的感知，并监控此禁用条件。

DESCRIPTION (provided by applicant): The goal of the proposed research is to further refine and evaluate an inconspicuous, awareness- enhancement and monitoring device (AEMD) which will assist the treatment of trichotillomania (TTM). TTM is associated with significant impairments in social functioning and often has a profound negative impact on self- esteem and well being. Conservative estimates suggest that 0.6% percent of the US population, or about 1.8 million people, meet full diagnostic criteria for TTM and approximately 7.5 million US residents have significant hair pulling problems. Of those treated, 60% to 70% are wholly or partially refractory to standard behavioral and pharmacological treatments and could therefore potentially benefit from this device. Best practice treatment for TTM involves a form of behavioral therapy known as habit reversal therapy (HRT). HRT requires persons with TTM to be aware of their hair pulling behaviors, yet the majority of persons with TTM pull most of their hair outside of their awareness. HRT also requires TTM sufferers to record the frequency and duration of their hair pulling behaviors yet it is impossible for a person to monitor behaviors that they are unaware of. Our Phase I efforts have produced a prototype device (AEMD) that solves these two problems. The prototype AEMD signals the TTM sufferer if their hand approaches their hair, thereby bringing pulling-related behavior into awareness. The prototype AEMD also logs the time, date, duration, and user classification of hair pulling related events. Our published pilot study and subsequent investigations establish that the prototype AEMD successfully alerts TTM sufferers to pulling-related behaviors and monitors TTM-related behavior in a laboratory setting. With respect to technological innovation, this project has the potential to develop the first available miniaturized, wearable, patient interactive, real-time data collecting and proximity-sensing device that both alerts sufferers to the presence of mental illness symptoms as they occur and keeps track of the frequency and intensity of the problem. The patented technologies developed for the AEMD have the potential to be of great value for a range of other health/mental health conditions or industrial applications. Our overall Phase II aim is to further refine the AEMD and to evaluate its acceptance and utility when used in an open trial course of professionally-led habit reversal therapy. It is hypothesized that the AEMD will be enthusiastically accepted by TTM sufferers and their clinicians and that it will perform as designed during the clinical trial. The Phase II AEMD will include a bracelet(s)/watch to be worn on each wrist, another element to be placed at the rear base of the neck, and a pager-like alert device to be worn at the belt-line or in a pocket. The AEMD, if found to be useful and effective, has the potential to significantly reduce the symptoms of TTM and its associated functional impairments. The AEMD also has great potential to improve assessment and monitoring of TTM behaviors which could be invaluable to clinicians planning treatment and to researchers evaluating the efficacy of various treatment strategies. PUBLIC HEALTH RELEVANCE: This Phase II project involves continued design, development and evaluation of a device that aids in the treatment of trichotillomania. The device enhanced awareness of pulling behavior and monitors this disabling condition.